Analytical Method Validation

In this review, we show a wide range of examples of the expanding use of multivariate analysis (MVA) in pharmaceutical manufacturing and control. MVA is being used to resolve numerous analytical challenges, such as overcoming matrix effects, extracting reliable data from dynamic matrices, and more.

It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.

Computerized system validation (CSV) has an uninspiring reputation for being a slow, no-value-added activity that only wastes time and delays the implementation of new software. Is that an accurate portrayal? And is it a necessary evil?

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.

Columnist Bob McDowall discusses operating system security patches.

Part IV of this four-part series wraps up the discussion of mass calibration, covering the "new generation" attributes that have become apparent as researchers aim to meet the calibration demands of proteomics.